POLARIS™ 5.5 SPINAL SYSTEM 14-578445Recalls & reported problems
Biomet Spine LLC · Class 2
All models of POLARIS 5.5 SPINAL SYSTEM (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304943247), received between Mar 18, 2025 and Mar 18, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT DURING A POST-OP FOLLOW UP APPOINTMENT, FIVE PLUGS WERE FOUND TO HAVE MIGRATED OUT OF THEIR TRANSLATING SCREWS. THE AFFECTED LEVELS ARE LOCATED AT RIGHT L3, RIGHT AND LEFT L4, AND RIGHT AND LEFT PELVIS. THE PATIENT IS ASYMPTOMATIC, SO A REVISION SURGERY IS NOT PLANNED. THIS IS REPORT EIGHT OF TEN FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21633470 ↗MalfunctionMar 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT DURING A POST-OP FOLLOW UP APPOINTMENT, FIVE PLUGS WERE FOUND TO HAVE MIGRATED OUT OF THEIR TRANSLATING SCREWS. THE AFFECTED LEVELS ARE LOCATED AT RIGHT L3, RIGHT AND LEFT L4, AND RIGHT AND LEFT PELVIS. THE PATIENT IS ASYMPTOMATIC, SO A REVISION SURGERY IS NOT PLANNED. THIS IS REPORT SEVEN OF TEN FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21633332 ↗MalfunctionMar 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT DURING A POST-OP FOLLOW UP APPOINTMENT, FIVE PLUGS WERE FOUND TO HAVE MIGRATED OUT OF THEIR TRANSLATING SCREWS. THE AFFECTED LEVELS ARE LOCATED AT RIGHT L3, RIGHT AND LEFT L4, AND RIGHT AND LEFT PELVIS. THE PATIENT IS ASYMPTOMATIC, SO A REVISION SURGERY IS NOT PLANNED. THIS IS REPORT SIX OF TEN FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21633328 ↗
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- EXPEDIUM TOP NOTCH 179771555Depuy Spine, LLC · Orthosis, spondylolisthesis spinal fixation41 reports
- EXPEDIUM 179712650Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation31 reports
- EXPEDIUM VERSE 199721530Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
- CD HORIZON® Spinal System 7576545Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation26 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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